When the FDA comes knocking, will your inspection be a success? YES

Transcription

1 PRESENTED BY EDUQUEST IN COOPERATION WITH FDA COMPLIANCE BOOT CAMP 2017 I Auditing, Data Integrity, and Quality Systems GET FIVE DAYS OF HANDS-ON, INTERACTIVE TRAINING! YOUR INSTRUCTORS OCT , 2017 HILTON GARDEN INN, FREDERICK, MD Near Baltimore and Washington, DC* When the FDA comes knocking, will your inspection be a success? YES when you have the same training the agency gives its own investigators. Denise Dion Vice President Regulatory & Quality Services Imagine getting inside the head of a working FDA investigator long before your next inspection. Without risking a single noncompliance penalty, you ll enjoy all the benefits of knowing what comes next from what the agency trains its investigators to look for... to which problems face the most scrutiny. You ll even know which of your systems would be first-up for inspection. Now you can capture that compliance confidence. And it takes less than a week. Experience a simulated investigation, pick up effective self-auditing techniques and so much more. Here s how... FDA Compliance Boot Camp s simulated inspection exercise is as close to the real thing as you re likely to get until the day the FDA actually knocks on your door. Janis Olson Vice President Regulatory & Quality Services FDA training now available to industry! Get your choice of two intensive courses in one week: FDA Auditing of Computerized Systems and Part 11/Annex 11 The CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations, and Complaint Management *The course location is accessible from three major airports (Baltimore-Washington International, Washington Dulles International, and Washington Reagan National) and two Interstate Highways (I-70 and I-270). Sharon Strause Senior Consultant

2 PRESENTED BY EDUQUEST IN COOPERATION WITH FDA COMPLIANCE BOOT CAMP 2017 COURSE 1: FDA Auditing of Computerized Systems and Part 11/Annex 11 DAY 1 Monday, Oct. 16 8:30 a.m. 8:45 a.m. I WELCOME AND CLASS INTRODUCTIONS 8:45 a.m. 10:30 a.m. Regulatory Framework for Computerized Systems: Introduction 10:45 a.m. 12:15 p.m. Part 11 and Annex 11: Analysis and Comparison of Key Requirements 1:00 p.m. 2:30 p.m. What Auditors Need to Know about Software Development & Computerized System Validation 2:30 p.m. 2:45 p.m. I BREAK 2:45 p.m. 4:30 p.m. Planning and Executing Audits for Computerized System Validation 4:30 p.m. 5:00 p.m. Introduction to Mock FDA Audit Scenarios 5:00 p.m. I ADJOURN DAY ONE 9:00 a.m. 10:15 a.m. Scenario #1 10:15 a.m. 10:30 a.m. I BREAK 10:30 a.m. 12:15 p.m. Scenario #1, continued 1:00 p.m. 2:00 p.m. Wrap-Up of Scenario #1: Lessons Learned and Key Take-Aways 2:00 p.m. 2:30 p.m. Introduction to Mock FDA Audit Scenario #2: Vendor-Hosted Learning Management System (LMS) 2:30 p.m. 2:45 p.m. I BREAK 2:45 p.m. 3:15 p.m. Mock FDA Audit Scenario #2: Group Review of Documents; Preparation of Audit Questions 3:15 p.m. 5:00 p.m. Scenario #2 5:00 p.m. I ADJOURN DAY TWO 9:30 a.m. 10:00 a.m. Introduction to Mock FDA Audit Scenario #3: Hybrid In-House/Off-the-Shelf Manufacturing Execution System (MES) 10:00 a.m. 10:15 a.m. I BREAK 10:15 a.m. 10:45 p.m. Mock FDA Audit Scenario #3: Group Review of Documents; Preparation of Audit Questions 10:45 a.m. 12:15 p.m. Scenario #3 1:00 p.m. 2:00 p.m. Scenario #3, continued 2:00 p.m. 3:00 p.m. Wrap-Up of Scenario #3: Lessons Learned and Key Take-Aways 3:00 p.m. 3:15 p.m. I BREAK 3:15 p.m. 4:30 p.m. Regulatory Enforcement: Overview and Trends 4:30 p.m. 5:00 p.m. Questions & Answers/Discussion DAY 2 Tuesday, Oct. 17 5:00 p.m. I ADJOURN CLASS DAY 3 Wednesday, Oct. 18 8:30 a.m. 9:00 a.m. 8:30 a.m. 9:30 a.m. Mock FDA Audit Scenario #1: Highly Configurable System; Group Review Wrap-Up of Scenario #2: Lessons Great job! I will watch for other of Documents; Preparation of Audit Learned and Key Take-Aways courses. Questions

3 PRESENTED BY EDUQUEST IN COOPERATION WITH FDA COMPLIANCE BOOT CAMP 2017 COURSE 2: The CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations, and Complaint Management DAY 4 Thursday, Oct. 19 7:30 a.m. 8:30 a.m. I REGISTRATION & CONTINENTAL BREAKFAST 8:30 a.m. 10:30 a.m. Regulatory Requirements for CAPA FDA s requirements for Corrective and Preventive Action systems Specific GLP, Drug GMP and Medical Device CAPA regulations Why CAPA systems continue to be at the top of FDA s enforcement list Role of CAPA in meeting global rules and standards 10:45 a.m. 12:30 p.m. Elements of Effective CAPA Systems Framework for a compliant CAPA system Where and how the CAPA feedback loop improves your overall quality system Definitions of a correction, corrective action, and preventive action and why the difference matters How companies like yours are organizing their CAPA systems 12:30 p.m. 1:30 p.m. I LUNCH BREAK 1:30 p.m. 3:30 p.m. CAPA Tools CAPA data sources gathering feedback from throughout your organization Recommended flow chart for CAPA data collection and closure Review of some commercially available CAPA management systems Key points to consider in picking the right CAPA tools for your needs 3:30 p.m. 3:45 p.m. I BREAK 3:45 p.m. 5:30 p.m. What to Look for in Failure Investigations/ Root Cause Analysis Key objectives and phases of failure investigations How to conduct a proper failure investigation to its root cause OOS investigations a special type Failure Investigations Tools What they are How they are used Reporting objectives 5:30 p.m. I ADJOURN DAY ONE DAY 5 Friday, Oct. 20 7:30 a.m. 8:30 a.m. I CONTINENTAL BREAKFAST 8:30 a.m. 10:30 a.m. Trending Requirements and CAPA Drug and device trending requirements what and when to trend Use of statistics to find and fix CAPA problems Often overlooked but critical internal and external feedback sources Use of Risk (Process, Product) to determine when and if to escalate to a CAPA 10:45 a.m. 12:30 p.m. FDA Enforcement Priorities Understanding FDA s mindset Inspection Observations and Reports Consequences of non-compliance Recent trends in FDA 483 observations Practical suggestions surviving an inspection CANCELLED Course Exam (Self-Test; Open Book) 12:30 p.m. I ADJOURN CLASS CONFERENCE TUITION Save $695 by registering for Track A Discounted fee: $3,895 Track A: Combination of Courses 1 and 2 Training Course #1: FDA Auditing of Computerized Systems and Part 11/Annex 11 (24 Course Hours) Fee: $2,995 Oct. 16, 17 & 18, 2017 Monday, Tuesday & Wednesday 8:30 a.m. to 5:00 p.m. Training Course #2: The CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations, and Complaint Management (12 Course Hours) Fee: $1,595 Oct. 19 & 20, 2017 Thursday, 8:30 a.m. to 5:30 p.m. Friday, 8:30 a.m. to 12:30 p.m.

4 PRESENTED BY EDUQUEST IN COOPERATION WITH FDA COMPLIANCE BOOT CAMP 2017 Auditing, Data Integrity, and Quality Systems Register Today! YES! Sign me up for the FDA Compliance Boot Camp 2017 Training Course #1: FDA Auditing of Computerized Systems and Part 11/Annex 11 Monday - Wednesday, 8:30 a.m. to 5:00 p.m. Training Course #2: The CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations, and Complaint Management Thursday, 8:30 a.m. to 5:30 p.m., Friday, 8:30 a.m. - 12:30 p.m. INFORMATION: Name Title Company Address City State ZIP Phone Fax PAYMENT OPTIONS: Save $695 by registering for Track A! $2,995 CANCELLED Track A: Combination of Courses 1 and 2 $3,895 Training Course #1: FDA Auditing of Computerized Systems and Part 11/Annex 11 Monday - Wednesday, 8:30 a.m. to 5:00 p.m. Training Course #2: The CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations, and Complaint Management Thursday, 8:30 a.m. to 5:30 p.m., Friday, 8:30 a.m. - 12:30 p.m. Toll-free: (888) c Check Enclosed: payable in U.S. funds to FDAnews c Charge my: c Visa c MasterCard c AmEx Card # Exp. Date Signature TUITION: Tuition of $3,895, $2,995 or $1,595 includes all course materials, lunch, refreshments, and the opportunity to learn and interact with some of the top FDA compliance experts in the nation. CANCELLATIONS/ SUBSTITUTIONS: Cancellations received before the beginning of a course will be subject to a refund according to the following schedule and rates: A 95% refund will be provided for cancellations received up to 6:00 PM EST, 10 business days in advance of the course start date. If less than 10 business days-advance notice is provided, the refund amount will be reduced to 50%. Substitutions are permitted with prior notification to FDAnews. Individuals requesting to change course location less than 10 business days in advance of the course will be charged a $500 administrative fee. No-shows will be charged the full amount. FDAnews reserves the right to cancel the courses and is not responsible for any airfare, hotel, or other costs incurred by registrants. TWO OR MORE TEAM DISCOUNTS: Significant tuition discounts may be available for teams from the same company. Register four members for the same course and send the fifth member for free. You must register at the same time and provide a single payment to take advantage of the discount. Call +1 (703) for details. FOUR EASY WAYS TO REGISTER: Please mention priority code BROCHU when registering HOTEL RESERVATIONS: To reserve your room, call the hotel at the number below. Be sure to tell the hotel Code EDUOCT to qualify for the reduced rate. Only reservations made by the reservation cutoff date are offered the special rates, and space is limited. Hotels may run out of discounted rates before the reservation cutoff date. Room cancellations within 72 hours of the date of arrival or no-shows will be charged for the first night s room with tax. Dates/Location: Oct , 2017 Hilton Garden Inn Frederick 7226 Corporate Court, Frederick, MD (240) maryland/hilton-garden-inn-frederick-iadfrgi/ index.html Room rate: $122, per night plus tax (Please mention discount code: EDUOCT) Reservation cut-off date: Oct. 2, 2017 Online: Fax: +1 (703) Phone: Toll free (888) (inside the U.S.) or +1 (703) Mail: FDAnews, 300 N. Washington St. Suite 200 Falls Church, VA USA

5 ABOUT YOUR INSTRUCTORS Denise Dion, vice president of regulatory and quality services with, spent 18 years with the FDA, where she served as an Office of Regulatory Affairs headquarters authority on agencywide inspections and investigations. She developed many of the FDA s inspection guidance and training materials, including serving as the primary editor of the well-known FDA Investigations Operations Manual (IOM). Denise was the primary contact for interpretation and request for changes and additions to the IOM. For her clients, Denise provides regulatory guidance with particular emphasis on cgmps, GCPs, quality systems, CAPA systems, risk management, bioresearch monitoring, and FDA inspections and enforcement. Denise regularly performs audits to assess regulatory compliance with drug, medical device and biologics regulations. Janis Olson, vice president of regulatory and quality services with. Previously, Janis worked at the FDA for more than 22 years, where among other responsibilities she conducted domestic and international inspections of FDA-regulated companies. Currently, Janis helps clients comply with GxP regulations worldwide. She also helps companies prepare for FDA inspections through training, reviewing computer validation documentation, and writing and updating SOPs. Janis was on the PDA task force that wrote the Good Electronic Records Management documents and has served as chair of the PDA industry advisory board for audits of computer system suppliers. She was an instructor for s national FDA training program on Part 11 and has written web-based training on computer system validation and Part 11. Sharon A. Strause is a national authority on computer systems validation and a member of s global consulting and training team. She has more than 20 years of experience in the pharmaceutical and medical device fields, including seven years in the Quality Assurance Division at McNeil and Johnson & Johnson Merck Pharmaceutical. Since 2004, she has been a consultant to the life science, consumer product, and software development industries. Previously, she worked 15 years at McNeil Consumer & Specialty Pharmaceuticals, a Johnson & Johnson Company. For seven of those years, she managed the Quality Sciences and Compliance Document Control Group that established standards, policies and practices for documentation at McNeil and Johnson & Johnson Merck Pharmaceutical. WHO SHOULD ATTEND Quality assurance/quality control Research and development Validation Information technology/transfer Electronic records Software development Regulatory affairs Internal auditing Document management Vendor management Laboratory information management systems Software and computerized systems procurement Clinical trial data ATTENDEES WILL LEARN What FDA investigators are trained to look for which systems they inspect first which problems get the most scrutiny Self-auditing techniques to use before the investigators call How to identify and implement corrections, corrective actions and preventive tools How to perform a computerized system validation How to choose the right risk management tools and methodologies for your organization Excellent, knowledgeable, interesting instructors. One of the best training [courses] I ever attended.